IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls

NCT04334473 | Completed

• 1 other identifier: N-45-2019
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

Conditions

Glaucoma; Cataract

Keywords

Ocular bio-metrics; Anterior chamber depth; UBM

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure change

  intraocular pressure measurement by Goldman's applanation tonometr

  4 weeks

• ocular bio-metrics change

  anterior chamber angle angle opening distance and anterior chamber depth change

  4 weeks

Secondary Outcomes (1)

• Phacoemulsification as treatment to glaucoma

  4 weeks

Study Arms (1)

cataract patients

OTHER

Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM.

Procedure: phacoemulsification and Intraocular lens implantation; Diagnostic Test: Ultrasound Biomicrosopy (UBM)

Interventions

phacoemulsification and Intraocular lens implantation PROCEDURE

Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.

cataract patients

Ultrasound Biomicrosopy (UBM) DIAGNOSTIC_TEST

A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.

cataract patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70 years.
• Glaucomtous and nonglaucomatous participants with visually significant cataracts.
• Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
• patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).

You may not qualify if:

• Major intraoperative or postoperative complications from cataract surgery
• Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
• Uveitis, severe retinal diseases, or congenital Anomalies.
• History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery

Sponsors & Collaborators

• Mai Nasser Abd Elmohsen: lead

Study Sites (1)

Faculty of medicine, Cairo university

Cairo, 11562, Egypt

Location

Related Publications (4)

• Elgin U, Sen E, Simsek T, Tekin K, Yilmazbas P. Early Postoperative Effects of Cataract Surgery on Anterior Segment Parameters in Primary Open-Angle Glaucoma and Pseudoexfoliation Glaucoma. Turk J Ophthalmol. 2016 Jun;46(3):95-98. doi: 10.4274/tjo.92604. Epub 2016 Jun 6.

  PMID: 27800269 BACKGROUND

• Melancia D, Abegao Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141-8. doi: 10.1159/000377635. Epub 2015 Mar 7.

  PMID: 25765255 RESULT

• Hsu CH, Kakigi CL, Lin SC, Wang YH, Porco T, Lin SC. Lens Position Parameters as Predictors of Intraocular Pressure Reduction After Cataract Surgery in Nonglaucomatous Patients With Open Angles. Invest Ophthalmol Vis Sci. 2015 Dec 1;56(13):7807-7813. doi: 10.1167/iovs.15-17926.

  PMID: 26650901 RESULT

• Man X, Chan NC, Baig N, Kwong YY, Leung DY, Li FC, Tham CC. Anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber drainage angle in primary angle-closure glaucoma (PACG) patients. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):773-8. doi: 10.1007/s00417-015-2936-z. Epub 2015 Feb 3.

  PMID: 25644619 RESULT

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Phacoemulsification; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Karim A Raafat, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of ophthalmology

Model Details: All participants are assigned to the same interventions. All will undergo pre- \& postoperative assessment, cataract surgery.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: September 20, 2019
• Primary Completion: March 15, 2020
• Study Completion: April 1, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)